This trial is fully enrolled. This means that all of the available places on the trial have been filled. You cannot enrol in this trial.
About this trial
This study is looking at two products, uridine and pravastatin, to see if they can help with lipoatrophy (the loss of fat from cheeks, limbs and buttocks). Over 28 weeks, the study will compare people who are being treated with one, both or neither of the products to see if there are any changes. The study will also monitor any side effects to see whether the products are safe.
Background information
Uridine is a nucleotide, or a protein 'building block', which previous studies have suggested may help improve fat loss or wasting associated with HIV medications. In this study, it will come in a powder form which can be dissolved in water and consumed.
Pravastatin is a drug, currently licensed to treat high cholesterolAn essential component of cell membranes and nerve fibre insulation, cholesterol is important for the metabolism and transport of fatty acids and the production of hormones and Vitamin D. Cholesterol is manufactured by the liver, and is also present in certain foods. High blood cholesterol levels have been linked to heart disease and may be a side effect of some anti-HIV medications., which research suggests may also help improve fat loss.
The study will compare uridine alone, uridine used with pravastatin, or pravastatin alone. You will be randomly assigned to one of these three groups, or to a delayed treatment armAny of the treatment groups in a randomised trial. Most randomised trials have two "arms," but some have three "arms," or even more.. If you are assigned to the delayed treatment arm, you will be offered the option of a combination of uridine and pravastatin after 28 weeks, for a period of six months.
| Official title: | A 28 weeks randomised, controlled comparison of uridine, pravastatin or uridine plus pravastatin to accelerate recovery of lipoatrophy in HIV-infected adults |
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| What is this trial studying? | New drug – uridine, pravastatin |
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| How many participants will this trial enrol? | 40 The exact number of participants may be lower or slightly higher than this. Some trials also have specific quotas for participants from each state, city or clinic. |
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| How long is this trial planned to go for? | Participants in this trial will be asked to take the trial drugs for 28 weeks. Following the conclusion of the trial, participants will be followed up for a further 24 weeks. |
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| Can I access this treatment other than by enrolling in this trial? | Pravastatin is a drug licensed in Australia to treat high cholesterolAn essential component of cell membranes and nerve fibre insulation, cholesterol is important for the metabolism and transport of fatty acids and the production of hormones and Vitamin D. Cholesterol is manufactured by the liver, and is also present in certain foods. High blood cholesterol levels have been linked to heart disease and may be a side effect of some anti-HIV medications.. It is available, subsidised and by prescription, for this condition. It is not currently indicated for treating HIV lipoatrophy. Uridine is marketed as a food supplement called Nucleomaxx, and can be purchased from the manufacturer.
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| Tags: | facial wasting, Lipodystrophy and lipoatrophy, uridine |
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Who can enrol in this trial?
You may be eligible to participate in this trial if you meet the following criteria:
- At least 18 years old
- HIV-positive
- Undetectable viral load (less than 50 copies) for at least three months
- Currently on a regimen, not including tenofovir, for at least three months
You
will not be eligible to participate in this trial if you meet any of the following criteria:
- Use of zidovudine (AZT) or stavudine (d4T) in the last 12 months
- Unable to tolerate lopiniavir/ritonavir (Kaletra)
- Kidney or renal problems
- High blood cholesterol or lipids requiring treatment with a statin drug
This is a summary of key inclusion and exclusion criteria for this trial. There may be other criteria which may exclude some people from participation in this trial. Some laboratory tests may also be required. Consult your doctor, or view the trial protocol or informed consent documentation to see the full range of exclusion and inclusion criteria.
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